Blood Bank of Alaska Position Description

Position Title: Technical Writer & Quality Systems Specialist Department: Quality Assurance Reports To: Director of Quality Assurance Date Updated: May 2022 Position(s) Supervised: None

POSITION SUMMARY

Blood Bank of Alaska (BBA) is seeking a detail-oriented Technical Writer & Quality Systems Specialist at our main campus in Anchorage, AK. For this full-time position, you will be a key member of the Quality Assurance team, providing the blood bank with essential support for quality processes and assessments. You should be someone excited by the idea of analyzing non-conformances and providing clear written evaluations of such discrepancies. Using your excellent communication skills and experience, you will collaborate with subject matter experts at all levels of the company to ensure that reports are complete and accurate. You should also enjoy the challenge of writing and editing procedures that are easy to follow and that consistently produce expected outcomes.

This role has a heavy focus reviewing procedural deviations and performing internal assessments. Excellent analysis, critical thinking, and written communications skills are required. Knowledge of blood banking, pharmaceutical manufacturing, or healthcare is certainly a plus.

This position will be responsible for:

Promoting organizational compliance with accrediting agency, state and federal regulations

Writing, revising, editing, and approving Standard Operating Procedures (SOPs)

Assisting document owners in writing and revising SOPs

Managing BBA's document control process

Ensuring consistency across departments when policies or procedures change

Performing investigations for occurrences

Performing internal audits

ESSENTIAL DUTIES AND RESPONSIBILITIES

Perform duties in compliance with all applicable regulatory and accrediting agencies. Ensure OSHA regulations and cGMPs are adhered to.

Perform occurrence investigations including Occurrence Reports (ORs), Post Donation Information (PDI), Biological Product Deviation Reports (BPDRs), and Quarantine and Lookback (Q&LB) for positive test results

Assist with the review, compilation, and submission of FDA reports, correspondence, product licensing, etc.

Develop operational audit plans, perform audits, write audit reports, and issue audit findings to department management. Audits include blood center processes, procedures, work areas, electronic queries, and documents.

Provide support during external agency inspections (FDA, AABB, etc.).

Manage record retention process and record storage areas.

Facilitate changes to Standard Operating Procedures (SOPs). This may include writing and updating policies, processes, and procedures.

Use software to prepare and edit SOPs, attachments, and forms, ensuring:

o Use of proper punctuation, grammar, spelling, and style

o Consistency of abbreviations, format, and terminology

o Clarity of content and incorporation of all required material

Assist document owners and management who write and revise SOPs.

Conduct research for creation of and changes to SOPs, utilizing manuals, periodicals, AABB standards, FDA regulations, and relevant sources.

Coordinate document control process with the Document Control Specialist.

Maintain positive communication with all departments. Promote a positive work environment in which staff work cooperatively towards objectives.

Exhibit support of BBA values, mission statement, quality objectives, and customer service standards at all times.

Perform other duties as assigned and qualified to do.

CUSTOMER INTERACTION/PROBLEM SOLVING

Must maintain a high standard for conscientious, courteous, and enthusiastic service to internal and external customers, and the public in general.

Must make customer’s needs a high priority in face-to-face, telephone, and email contact.

Must consistently deliver service in a timely, accurate, professional, and friendly manner.

Must demonstrate a high level of problem-solving skills.

QUALIFICATION REQUIREMENTS

To perform this job successfully, each essential duty (as listed above) must be performed satisfactorily. The requirements listed below are representative of the knowledge, skill, and ability required.

GENERAL KNOWLEDGE, SKILLS, AND ABILITIES

Highly detailed orientated.

Strong computer skills, Proficient in Microsoft Office applications (Word, Excel, PowerPoint).

Ability to work independently, self-motivating, perform tasks of a detailed nature accurately within required timeframes, and adapt to fluctuating workloads.

Exceptional organizational skills and ability to prioritize work.

Thorough knowledge of business English, spelling, and punctuation. Effective written and verbal communication skills. Excellent writing ability for technical, professional, and other related documents.

Ability to demonstrate strong technical writing skills given initial information pertaining to subject matter and identify changes needed in documents and promote implementation of changes effectively in a timely manner.

Ability to problem solve at a high level through interpretation of regulatory guidelines, applicable laws and statures, industry standards, and quality-focused decision making.

Demonstrate ability to network with internal and external resources, build relationships conducive to a quality environment and continue growth in knowledge areas related to industry.

Ability to instruct and train document owners and authors on writing and updating documents in Q-Pulse.

Ability to instruct and train copyholders on preparing staff reading lists and maintaining SOP manuals.

Ability to instruct and train staff in additional Q-Pulse modules.

Ability to organize and maintain company records.

Ability to interface effectively and harmoniously with employees, public, and regulatory inspectors.

Knowledge of general safety and quality assurance procedures.

Ability to maintain confidentiality of donors, customers, employees, and BBA business information.

Ability to work in an ever changing environment.

EDUCATION

Associate's or Bachelor's Degree in relevant field strongly preferred (English, journalism, etc.). Experience may be substituted with a demonstrated ability to perform regulatory interpretation and advanced technical writing.

EXPERIENCE

Minimum two or three years of journalism or technical writing.

CERTIFICATES, LICENSES, ETC. Minimum: Valid Driver’s License

WORK ENVIRONMENT

Extensive use of computers.

Must be able to lift at least 30 pounds and sit for long periods of time.

Potential hazard due to exposure to blood or other potentially infectious materials. The Blood Bank of Alaska follows OSHA Bloodborne Pathogens Standards in the workplace.

Must be able to walk moderate distances, climb stairs, reach, push, pull, and bend in order to perform his/her job duties.